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From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD

NCT06227598 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2024-01-29

No results posted yet for this study

Summary

This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https://algae4ibd.eu/), where Dept. of Molecular Medicine and Medical Biotechnologies (DMMBM) University of Naples Federico II participates as a partner. It aims to promote the implementation of the European Crohn's and Colitis Organization (ECCO/FECCO) Directive and the benefit of the Inflammatory Bowel Disease (IBD) patient's wellness by finding innovative algae based novel small molecule therapeutics. A systemic approach to eco-innovation is adopted to create interconnections between sectors, value chains, natural resources, and relevant societal stewards. To this end, the consortium has set specific objectives to achieve holistic innovations, including technical, economic, health, and social factors that all work in concert.

IBD included Crohn's disease and ulcerative colitis. It is a class of chronic inflammatory disorders with complex pathogenesis. Despite the lack of a full understanding of its etiogenesis, many anti-inflammatory treatments have been developed over the last decades. However, not all patients may benefit from these treatments and some of them are refractory to the current therapies or experience relapse of the disease. Therefore, there is still an urgent need to find an innovative line of interventions for ameliorating these patients' overall quality of life.

Algae4IBD consortium will form a bridge between innovation and market demands to prevent and treat inflammation, pain, and IBD. Bioactive molecule/compounds extracts from microalgae, cyanobacteria, and macro-algae (MiaCyMa) are an inexhaustible untapped natural source for products destined for IBD prevention and treatment (inflammation, pain, and the disease process associated with the gut's microbiome). The natural source potential is still more promising when considering extremophile strains for excellent metabolism systems. Moreover, the production of the natural source of biological materials should be sustainable. Indeed, the non-genetically modified organisms (GMO cultures offer numerous advantages such as reduced requirements of fresh water and land (no arable land is required), drastic reduction of nitrogen sources, and potential environmental threats. Algae4IBD concept will include a multi-step screening approach and feedback loops across the project steps to achieve its goals. Specifically, DMMBM is in charge with work package (WP) 4, task 4.4.2, which aims to characterize the activity of plant cell (algae) extracts named in this proposal as "natural compounds" of algae provided by the consortium in ex-vivo models, using bioptic samples derived from patients with IBD (patients with ulcerative colitis (UC) and Crohn's disease (CD)), comparing them to samples derived from patients without UC and CD.

Conditions

Interventions

OTHER

Procedure: Additional biopsies collection

Procedure: Additional biopsies collection We will recruit only subjects (UC, CD and NO-UC/CD) scheduled for the endoscopy and biopsies-collection according to the usual clinical practice. During the endoscopy we will collect 6 additional biopsies.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-09-01
Completion
2026-09-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227598 on ClinicalTrials.gov